FDA 510(k) Application Details - K072990

Device Classification Name Temporary Carotid Catheter For Embolic Capture

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510(K) Number K072990
Device Name Temporary Carotid Catheter For Embolic Capture
Applicant MEDTRONIC INC.
37A CHERRY HILL DRIVE
DANVERS, MA 01923 US
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Contact KAREN A BROZOWSKI
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Regulation Number 870.1250

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Classification Product Code NTE
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Date Received 10/24/2007
Decision Date 10/31/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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